FDA product code SEM: Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
SEM is the FDA product code for sub-scalp implanted electroencephalogram system for remote patient monitoring. It is a Class II device, regulated under 21 CFR 882.1360 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SEM, 1 in the last five years. The average 510(k) review took 205 days (median 205); 205 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patients brain. The device is not intended to be implanted in brain tissue.
Classification
| Field | Value |
|---|---|
| Device name | Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring |
| Device class | Class II |
| Regulation | 21 CFR 882.1360 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SEM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 205 |
Compare with all 510(k) review times · Search every SEM clearance
Top SEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Uneeg Medical A/S | 1 | 2026-06-11 |
Most recent SEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253607 | Uneeg Medical A/S | UNEEG EpiSight System | 2026-06-11 | 205 |
Recalls for SEM devices
openFDA lists no recalls for product code SEM.
Frequently asked questions
What is FDA product code SEM?
SEM is the FDA product code for sub-scalp implanted electroencephalogram system for remote patient monitoring. It is a Class II device, regulated under 21 CFR 882.1360 and reviewed by the Neurology panel.
What device class is SEM?
Class II, regulation 21 CFR 882.1360. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEM?
Across 1 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most SEM clearances?
Uneeg Medical A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEM
- Run a recall and safety report across every SEM manufacturer
- Watch product code SEM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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